# K201555: EchoGo Pro

- Pathway: 510(k) (Traditional)
- Applicant: Ultromics, Ltd.
- Decided: Dec 18, 2020 after 191 days
- Product code: POK (Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer)
- Device class: 2
- Regulation: 21 CFR 892.2060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K913770 (1991). 15 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190442: Koios DS for Breast, Koios Medical, Inc. (2019) Summary page 5.

## Most influential descendants
- K242342: Fetal EchoScan (2024), 2 descendants of its own
- K251071: Fetal EchoScan (v1.1) (2025), 1 descendant of its own
- K254161: Automated Aortic Stenosis Software (AutoAS) (2026), 0 descendants of its own
- K252294: Fetal EchoScan (v1.2) (2025), 0 descendants of its own
- K241245: EchoSolv AS (2024), 0 descendants of its own

## Indications for use
EchoGo Pro v1.0.2 is a machine learning-based decision support system, indicated as an adjunct to diagnostic stress echocardiography for patients undergoing assessment for coronary artery disease (CAD). When utilized by an interpreting physician, this device provides information that may be useful in rendering an accurate diagnosis. Patient management decisions should not be made solely on the results of the EchoGo Pro v1.0.2 analysis. EchoGo Pro v1.0.2 is to be used with stress echo exam protocols that contain A2C, A4C and mid-ventricular short-axis views at rest and at peak stress. EchoGo Pro v1.0.2 is not intended for the assessment of mild or moderate myocardial ischemia, or localization of coronary artery disease, or for the assessment of myocardial perfusion, myocardial viability or valve disease. Limitations: EchoGo Pro v1.0.2 has not been validated on patients who underwent previous coronary artery bypass graft (CABG) surgery

Source page: https://510kreport.com/device/K201555
Methodology: https://510kreport.com/methodology